CGN · Acid, Folic, Radioimmunoassay
Clinical Chemistry · 21 CFR 862.1295 · Class 2
Overview
| Product Code | CGN |
|---|---|
| Device Name | Acid, Folic, Radioimmunoassay |
| Regulation | 21 CFR 862.1295 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233060 | Elecsys Folate III | Roche Diagnostics | Jun 17, 2024 | SESE |
| K223590 | Access Folate Assay | Beckman Coulter, Inc. | Aug 23, 2023 | SESE |
| K192586 | LIAISON® Folate | DiaSorin, Inc. | May 6, 2020 | SESE |
| K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | Apr 12, 2018 | SESE |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | Diazyme Laboratories | Nov 4, 2016 | SESE |
| K141426 | ELECSYS FOLATE III | Roche Diagnostics | Oct 17, 2014 | SESE |
| K103716 | ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET | Roche Diagnostics | May 12, 2011 | SESE |
| K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 | Abbott Laboratories | Mar 5, 2010 | SESE |
| K091332 | AIA-PACK RBC FOLATE | Tosoh Bioscience, Inc. | Oct 2, 2009 | SESE |
| K082340 | ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS | Roche Diagnostics Corp. | Jun 19, 2009 | SESE |
| K060774 | FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 | Beckman Coulter, Inc. | Apr 21, 2006 | SESE |
| K051292 | ELECSYS RBC FOLATE HEMOLYZED REAGENT | Roche Diagnostics Corp. | Jun 17, 2005 | SESE |
| K043318 | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY | Roche Diagnostics Corp. | Dec 23, 2004 | SESE |
| K031756 | ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY | Roche Diagnostics Corp. | Jun 25, 2003 | SESE |
| K023397 | ABBOTT ARCHITECT FOLATE | Abbott Laboratories | Dec 16, 2002 | SESE |
| K010050 | ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY | Bayer Diagnostics Corp. | Feb 5, 2001 | SESE |
| K001266 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA | Ortho-Clinical Diagnostics, Inc. | May 2, 2000 | SESE |
| K993254 | IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 | Diagnostic Products Corp. | Nov 12, 1999 | SESE |
| K992365 | AIA-PACK FOLATE ASSAY | Tosoh Medics, Inc. | Aug 10, 1999 | SESE |
| K991582 | CHIRON DIAGNOSTICS ACS: 180 FOLATE | Chiron Diagnostics Corp. | Jun 30, 1999 | SESE |
Top Applicants
- Abbott Laboratories — 5 clearances
- Beckman Coulter, Inc. — 5 clearances
- Bio-Rad — 5 clearances
- Diagnostic Products Corp. — 4 clearances
- Roche Diagnostics Corp. — 4 clearances
